FDA approves Shionogi's Osphena for postmenopausal women experiencing pain during sex

The US Food and Drug Administration yesterday approved Japanese drug major Shionogi’s (TYO: 4507) Osphena (ospemifene) to treat women experiencing moderate-to-severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.

“The FDA approval of Osphena represents an important advancement in the treatment of dyspareunia, providing an alternative treatment option for the millions of women living with this condition,” said John Keller, president and chief executive of Shionogi’s US subsidiary, adding: “We look forward to building our product portfolio in women’s health by advancing important therapies, such as Osphena.”

No product is marketed specifically for this use, noted Bloomberg, noting that Osphena may generate $495 million in sales in 2017, according to Naomi Kumagai, an analyst with Jefferies & Co in an e-mail to the news wire before the announcement.